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NOT YET RECRUITING
NCT07594912
PHASE2

Teprotumumab N01 Versus Methylprednisolone After Urgent Orbital Decompression for Dysthyroid Optic Neuropathy

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

Summary

This study aims to evaluate the efficacy and safety of sequential Teprotumumab N01 compared with intravenous methylprednisolone (IVMP) after urgent orbital decompression in patients with dysthyroid optic neuropathy (DON).

Official title: A Single-Center, Prospective, Randomized, Open-Label, Parallel-Group Study Comparing Sequential Teprotumumab N01 With Intravenous Methylprednisolone After Urgent Orbital Decompression in Patients With Dysthyroid Optic Neuropathy

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-08

Completion Date

2028-04

Last Updated

2026-05-19

Healthy Volunteers

No

Interventions

DRUG

Teprotumumab N01

Teprotumumab N01 will be administered intravenously after urgent orbital decompression. The first infusion will be 10 mg/kg, followed by 20 mg/kg every 3 weeks for 7 additional infusions.

DRUG

Intravenous Methylprednisolone (IVMP)

IVMP will be administered after urgent orbital decompression at 0.5 to 1.0 g per day for 3 consecutive days, followed by oral prednisone tapering according to the participant's clinical status and investigator judgment.

Locations (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, China